Model Based Fast Anatomical Mapping (MFAM)
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|ClinicalTrials.gov Identifier: NCT03349476|
Recruitment Status : Enrolling by invitation
First Posted : November 21, 2017
Last Update Posted : October 7, 2021
|Condition or disease||Intervention/treatment||Phase|
|Paroxysmal Atrial Fibrillation Persistent Atrial Fibrillation||Device: MFAM||Not Applicable|
This prospective, multicenter observational study will examine the ability of model based fast anatomical mapping (mFAM) to create left atrial (LA) geometry for atrial fibrillation ablation.
Specifically, the study will assess the following issues in atrial fibrillation ablation:
- Accuracy of map (defined as the distance between the ablation points and the surface of the mFAM geometry)
- Left atrial geometry creation time
- Fluoroscopy time
The clinical team will hypothesize that this approach will lead to accurate LA geometry creation more rapidly and using less fluoroscopy than standard techniques
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Left Atrial Anatomy Reconstruction Using Model Based Fast Anatomical Mapping|
|Actual Study Start Date :||April 16, 2018|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
The mFAM Workstation is a computerized system used to reconstruct the shape of the left atrium of the heart, by fitting a parametric shape model to points data acquired by a catheter.
The mFAM Workstation uses recorded catheter positions and other data inputs collected from various types of multi-electrode catheters and generates output data files that can be displayed as a 3D anatomic structure.
Specifically, the mFAM Workstation accesses stored data of recorded electronic heart activity that has been obtained by conventional electrophysiological methods, using multi-electrode catheters placed in the heart (data inputs) for collection. Using proprietary software algorithms, the mFAM Workstation analyzes these data inputs and generates 3D anatomical structure.
mFAM improves on the FAM functionality by applying a model-based approach for reconstruction of left atrial chamber anatomy
- Accuracy of map [ Time Frame: hospital discharge, average 24 hours post procedure ]Accuracy of map (defined as the distance between the ablation points and the surface of the mFAM geometry)
- Left atrial geometry creation time [ Time Frame: hospital discharge, average 24 hours post procedure ]The amount of time it takes to create the geometrical map using Carto and MFAM during the ablation procedure
- Fluoroscopy amount [ Time Frame: hospital discharge, average 24 hours post procedure ]The amount of Fluoroscopy (radiation) used during the ablation procedure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349476
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Mohit Turagam, MD||Icahn School of Medicine at Mount Sinai|
|Study Chair:||Vivek Reddy, MD||Icahn School of Medicine at Mount Sinai|